TemporaryFDAOngoing
Can cause harm that is usually temporary.
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Check the device or its packaging for
Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;
- Why
- Potential for false negative patient results.
- Distributed
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.
- Company
- DRG International, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0082-2027 · retrieved 2 October 2026
Read the official notice